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Product NDC Code | 66424-562 | ||||
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Drug Name | Senna syrup |
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Type | Brand | ||||
Active Ingredients |
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Route | ORAL | ||||
Dosage Form | SYRUP | ||||
RxCUI drug identifier | 702311 | ||||
Application Number | part334 | ||||
Labeler Name | SDA Laboratories, Inc. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each 5 ml) Sennosides 8.8 mg
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions • shake well before use • take preferably at bedtime or as directed by a doctor Age Starting Dose Maximum dosage adults and children 12 years and older 2-3 teaspoonfuls once a day 3 teaspoonfuls twice a day 6 years to under 12 years of age 1-1½ teaspoonfuls once a day 1½ teaspoonfuls twice a day 2 to under 6 years of age 1/2-3/4 teaspoon once a day 3/4 teaspoon twice a day under 2 years of age ask a doctor ask a doctor
2-3 teaspoonfuls once a day | 3 teaspoonfuls twice a day | |
1-1½ teaspoonfuls once a day | ||
1/2-3/4 teaspoon once a day | 3/4 teaspoon twice a day | |
under 2 years of age | ask a doctor | ask a doctor |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredient: flavors, methyl paraben, propyl paraben, sucrose and water.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses • relieves occasional constipation (irregularity) • generally causes bowel movement in 6 to 12 hours
Purpose
Information about the drug product’s indications for use.Purpose Laxative
Spl product data elements
Usually a list of ingredients in a drug product.SENNA Syrup Sennosides A and B SENNOSIDES A AND B SENNOSIDES A AND B METHYLPARABEN PROPYLPARABEN SUCROSE WATER dark brown
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Packaging Sennasyp
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Natural Vegetable Laxative For Gentle, Relief of Constipation * Compare to Active ingredient of Senokot® * This product is not manufactured or distributed by the owner of the registered trademark Senokot® Distributed By: SDA Laboratories Inc. 280 Railroad Ave. Greenwich, CT. 06830
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center immediately.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.TO REPORT ADVERSE DRUG EVENTS CALL 800-687-0176
Storage and handling
Information about safe storage and handling of the drug product.Other information • Store at room temperature 15°-30°C (59°-86°F) TAMPER EVIDENT: Do not use this product if breakaway band on cap is broken or missing
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings Do not use • laxative products for longer than 1 week unless directed by a doctor Ask a doctor or pharmacist before use if you have • stomach pain • nausea • vomiting • notice a sudden change in bowel movement that continues over a period of 2 weeks Stop use and ask a doctor if you have rectal bleeding or failure to have a bowel movement after use of laxative. These may indicate a serious condition If pregnant or breast-feeding, ask a health professional before use
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API